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Comparative Study of Non-contact Tonometers for Intraocular Pressure and Corneal Cell Thickness Measurements

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ClinicalTrials.gov Identifier: NCT02138279
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Study Description
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Brief Summary:
The primary objective of this clinical study is to collect clinical data to support FDA 510(k) submissions for the Topcon CT-800, CT-1, CT-1P and TRK-2P non-contact tonometers. The secondary objective is to evaluate any adverse events found during the clinical study.

Condition or disease
Intraocular Pressure Corneal Pachymetry

Study Design
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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Study of the Topcon Tonometers - CT-800, CT-1, CT-1P and TRK-2P to Demonstrate Conformance to ANSI Z80.10-2009 Ophthalmic Instruments -Tonometers, to the FDA Guidance for Industry and FDA Staff, Tonometer-Premarket Notification [510(k)] Submissions, and to the Applicable Supplemental Information Sheet and Comparison of Pachymetry Values for CT-1P and TRK-2P With the Konan CellChek Plus (Predicate)
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014
Groups and Cohorts
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Group/Cohort
Male and female adults 18+ years of age


Outcome Measures
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Primary Outcome Measures :
  1. Agreement of intraocular pressure measurements from predicate vs. investigational device [ Time Frame: Single timepoint - 1 day ]
  2. Agreement of central corneal thickness measurements from predicate vs. investigational device [ Time Frame: Single time point - 1 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ophthalmology practice
Criteria

Inclusion Criteria:

  • At least 18 years of age of either sex and any race or ethnicity;
  • Willing and able to provide written informed consent prior to any study procedures being performed;
  • Willing and able to follow all instructions and attend all study visits;
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 0.3 logMAR (20/40 Snellen equivalent) or better in both eyes as measured using an ETDRS chart.

Exclusion Criteria:

  • Only one functional eye;
  • Poor or eccentric fixation;
  • Corneal scarring or have had corneal surgery, including corneal laser surgery;
  • Microphthalmos;
  • Buphthalmos;
  • Contact lens wearer, meaning having worn soft contact lenses within the past 3 months and/or rigid permeable gas lenses within the past 6 months;
  • Dry eyes, meaning having been diagnoses by a physician with dry eyes and currently using a prescribed medication;
  • Lid squeezer - blepharospasm;
  • Nystagmus;
  • Keratoconus;
  • Any other corneal or conjunctival pathology or infection;
  • Condition or a situation, which in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138279


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Topcon Medical Systems, Inc.
More Information
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT02138279    
Other Study ID Numbers: TOPCON-TON-US-0001
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: November 2014